Ionis most likely gets Tegsedi approval with black box, says Morgan Stanley
Morgan Stanley analyst David Lebowitz laid out three potential scenarios for the upcoming FDA approval decision about Ionis Pharmaceuticals' Tegsedi, which is scheduled to come on or before October 6. If the FDA were to issue a complete response letter, or CRL, and prevent on-time launch, Lebowitz sees greater than 20% downside for the shares, though he puts the probability of this occurring at 40%. If Tegsedi is approved with a black box safety warning, which he sees as the most likely scenario with odds he pegs at 45%, Lebowitz sees the stock trading up or down about 5%. If Tegsedi is approved with a "clean" label it would lead to a steeper ramp in revenue and Lebowitz sees 20% or more upside to the stock in this scenario, though he puts the odds at just 15%. He maintains an Equal Weight rating on Ionis shares ahead of the PDUFA with a $45 price target.
10/07/18
PIPR
10/07/18 NO CHANGETarget $160 PIPR Overweight
Alnylam's Onpattro highly efficacious, safer than competitor, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff notes that Ionis Pharmaceuticals (IONS) announced FDA approval of TEGSEDI for treatment of hATTR polyneuropathy. The analyst also points out that the label includes a Black Box warning for thrombocytopenia and glomerulonephritis requiring every 2-week monitoring, and will be marketed by Ionis subsidiary Akcea (AKCA) with a Risk Evaluation and Mitigation Strategy. TEGSEDI is administered subcutaneously every week versus Alnylam's (ANLY) ONPATTRO intravenously every 3 weeks with steroids, he adds. Tenthoff believes that ONPATTRO appears safer and highly efficacious, and should win out. The analyst reiterates an Overweight rating and $160 price target on Alnylam shares.
10/08/18
CANT
10/08/18 INITIATIONTarget $135 CANT Overweight
Cantor reiterates Overweight on Alnylam after Akcea, Ionis win approval
Cantor Fitzgerald analyst Alethia Young reiterates an Overweight rating on Alnylam Pharmaceuticals (ALNY) with a $135 price target after the FDA approved Tegsedi, to be marketed by Akcea Therapeutics (AKCA). The analyst says that while the approval introduces another competitor to the market, she still expects Alnylam's Onpattroto be able to take significant share in the polyneuropathy hATTR market. Young thinks the Tegsedi label is more onerous and currently models a 60% peak share to Alnylam, a 25% share to Tegsedi and 15% to future competition.
10/08/18
GSCO
10/08/18 NO CHANGETarget $36 GSCO Sell
Ionis' Tegsedi to face commercial headwinds, says Goldman Sachs
After the FDA approved Ionis (IONS) and affiliate Akcea Therapeutics' (AKCA) Tegsedi for adult polyneuropathy of hereditary transthyretin-mediated amyloidosis, but with a black box warning, Goldman Sachs analyst Salveen Richter said he believes the drug faces commercial headwinds. He cites the underlying safety profile and requirement for consistent monitoring as well as the recent launch of Alnylam's (ALNY) Onpattro and expected launch of Pfizer's (PFE) tafamidis in the first half of 2019. Richter keeps a Sell rating on Ionis shares with a price target of $36.